MAUDE Adverse Event Report: MEDCOMP 8.0F X 12CM HEMO-CATH; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number MCBL800

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

Rn states, "attempted to draw labs from internal jugular.Was only able to draw back 0.2 ml from red lumen.Drew back 0.2 ml from blue lumen and then found to be drawing back free air.Clamped both lumens.Chest x-rays ordered.Dialysis nurse did clave change on both lumens, red lumen working well, was able to draw labs and high dose hep lock, blue lumen still drawing back free air.Performed dressing change, no obvious leaks or dislodgment seen.Per team huddle and attending decision, patient as of now will not need dialysis and blood products can be given via peripheral intravenous, it was decided to pull ij.Upon inspection of tube it was found to have a ~0.5 cm crack on central part of tubing, before the hub that bifurcates on the posterior side, flush with patient's skin.The ij was not used previous to these findings, blue lumen was not flushed after air draw back.Manufacturer response for dialysis cvc - double lumen, dialysis cvc- medcomp hemo-cath st double 8.0 fr 12.0 cm (per site reporter): returned call.Stated would follow up for the return of product.

• Brand Name: 8.0F X 12CM HEMO-CATH
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6614033
• MDR Text Key: 76734847
• Report Number: 6614033
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: MCBL800
• Other Device ID Number: DOUBLE LUMEN 8.0 F X 12.0CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1